What is the difference between the standards and the guidance document?

Refer to Sections 1, 2 the NAPRA Guidance Document for Pharmacy Compounding of Non-sterile Preparations. 

The College adopted NAPRA Model Standards for Pharmacy Compounding of Non-Sterile Preparations and Guidance Document for Pharmacy Compounding of Non-sterile Preparations, as the standard for non-sterile compounding in Ontario. 

Standards outline the minimum mandatory expectations that must be met by the profession, using the language of “must.” Therefore, these Model Non-Sterile Compounding Standards represent the minimum requirements to be applied in compounding to ensure the overall quality and safety of non-sterile preparations. 

Each standard has a corresponding section in the Guidance Document with details concerning how the standard can be achieved. The Guidance Document was developed by NAPRA as a supplemental resource and establishes professionally-accepted means by which pharmacies can achieve compliance with the standards. 

Where the guidance uses the language of “should”, it may be acceptable to meet the required standard using other technologies, techniques, materials and procedures than those suggested, if they have been proven to be equivalent or superior to those described in the Guidance Document.